# K092470: Optical Coherence Tomography 3D Oct-2000

- Pathway: 510(k) (Special)
- Applicant: Topcon Corp.
- Decided: Sep 2, 2009 after 21 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K063388 (2007). 3 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness, Topcon Medical Systems, Inc. (2009) Summary page 2.
- K083316: 3D Oct-1000 Mark II Optical Coherence Tomography System, Topcon Medical Systems, Inc. (2009) Summary page 2.

## Cited in the summary but kept off the family tree
- K063888: 3D OCT-1000. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K150467: Retina Workplace (2015), 3 descendants of its own
- K133217: Cirrus Photo (2014), 3 descendants of its own
- K180858: CALLISTO eye (2018), 2 descendants of its own

## Indications for use
The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.

Source page: https://510kreport.com/device/K092470
Methodology: https://510kreport.com/methodology